Safety & Efffficacy of Genakumab in Patients With Frequent Flares

Keywords

• Acute Gout Arthritis

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 111 studies on the registry; 48 are open to participants now.

Study arms

• Experimental
  Genakumab

  Genakumab 200mg s.c

  Drug: genakumab · Drug: placebo for Diprospan

• Active comparator
  Diprospan

  Diprospan 7mg im

  Drug: placebo for genakumab · Drug: Diprospan

Interventions

• Druggenakumab

  200mg s.c.

  Also known as: • Gensci048

• Drugplacebo for Diprospan

  i.m.

• Drugplacebo for genakumab

  s.c.

• DrugDiprospan

  Drug page: Betamethasone dipropionate

  7mg i.m.

Primary outcomes

1. The change in the gout pain intensity in the target joint measured by VAS

   The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. In this study patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0mm) to unbearable pain (100mm), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

   Time frame: 72 hours post-dose

2. Time to first new flare

   Time frame: 12 weeks

Secondary outcomes

1. Patients assessment of gout pain intensity in the target joints measured by VAS(0-100mm)

   Time frame: At 6, 24, 48, and 72 hours and 7 days post-dose

2. The change in the gout pain intensity in the target joint measured by VAS.

   Time frame: At 6, 24, 48, and 72 hours and 7 days post-dose

3. The number of patients with at least 1 new gout flare

   Time frame: 12 weeks, 24 weeks, 48 weeks

4. Time to at Least a 50% Reduction in Baseline Pain Intensity

   Time frame: 7 days

5. Percent Patients Who Took Rescue Medication

   Time frame: 24 weeks,48 weeks

6. Time to first flare

   Time frame: 24 weeks, 48 weeks

7. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

   Time frame: 24weeks, 48weeks

8. Immunogenicity The incidence of anti-drug antibodies (ADA) and the incidence of neutralizing antibody

   Time frame: 24 weeks, 48 weeks

9. Genakumab Pharmacokinetics (PK) Serum Concentration During the Treatment Period

   Blood was collected for Ganakumab levels at2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose.

   Time frame: 2 hours pre-dose, Days 4，8，29，57，85，169，253 days post-dose

Other outcomes

1. High Sensitivity C-reactive Protein (hsCRP)

   Time frame: 72 hours, 7 days and 4 weeks post-dose

2. SF-36

   The SF-36 measures the impact of disease on overall quality of life (QoL). This 36-item survey has 8 subscales that can be aggregated into physical- and mental-component summary scores. Scores are standardized with the use of norm-based methods based on an assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.

   Time frame: 8 weeks, 24 weeks and 48 weeks

Publications

• Zhu Z, Xue Y, Chu T, Hu J, Gou W, Zhang N, Li J, Yu J, Li R, Li R, Qian L, Duan X, Duan L, Xu Q, Gu F, Lian Y, Zhang X, Zou H. Efficacy and Safety of Firsekibart in Patients with Acute Gout Unsuitable for Standard Therapy: 48-Week Results from an Open-Label Extension of a Randomized Phase 3 Trial. Adv Ther. 2026 Aug;43(8):3432-3450. doi: 10.1007/s12325-026-03611-6. Epub 2026 May 19. PubMed 42154367 ↗

Individual participant data

Plan to share: Undecided